Positive Phase III results for Debio 8206 CPP (triptorelin pamoate slow release) in central precocious puberty- Debiopharm

Debiopharm has announced the completion of an international, multicenter, non-comparative phase III study with Debio 8206 CPP (triptorelin pamoate slow release) 22.5 mg 6-month formulation in 44 patients (39 girls and 5 boys) with central precocious puberty. The mean age of the patients at the time of diagnosis was 7 years (range 1 to 9 years). The results of this 12-month study show that the triptorelin 6-month formulation is efficacious in suppressing the pituitary release of LH (luteinizing hormone) and FSH (follicle-stimulating hormone), and consequently the gonadal secretion of estradiol in girls and testosterone in boys to prepubertal levels, with favorable effects on progression of clinical signs of puberty and bone maturation.

The percentage of children with prepubertal LH levels exceeded 93% at each time point on-treatment and reached 98% at month 12 when all but one patient were suppressed. The clinical signs of puberty (Tanner) were stable or reduced in the vast majority of patients (89%) between baseline and month 12. Administration of the triptorelin 6-month formulation was well tolerated and safe with no unexpected adverse events reported.

Comment: Debiopharm has developed three slow-release formulations (1, 3 and 6 months) of triptorelin pamoate. The 1- and 3-month-formulations have been registered in most countries and are currently available under the names of Trelstar in North America, Decapeptyl/Pamorelin in Europe, Latin America and Pamorelin in India. The 6-month-formulation has been registered and is available in Europe and the US in prostate cancer.